A Study of Bimagrumab Alone (LY3985863) and Bimagrumab With Tirzepatide (LY900042) in Healthy Participants

Phase 1

Recruiting

• Conditions: Healthy
• Interventions: Drug: Bimagrumab; Drug: Bimagrumab + Tirzepatide Coformulation; Drug: Tirzepatide

• Registration Number: NCT06890611
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study is to evaluate the body concentration of different forms of bimagrumab, administered alone or with tirzepatide. Participation in the study will last about 4.5 months, including screening and follow-up.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-18
• Study First Submitted QC: 2025-03-18
• Study First Posted: 2025-03-24
• Study Start: 2025-03-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-17
• Last Update Posted: 2025-04-18
• Primary Completion: 2025-11
• Study Completion: 2025-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Are considered healthy as determined by medical evaluation including medical history and physical examination
• Have a body mass index (BMI) within the range of 22.0 to 30.0 kilograms per square meter (kg/m2), inclusive

Exclusion Criteria

• Have current or a history of pancreatitis or hepatitis
• Have a self-reported increase or decrease in body weight, greater than 5 kilograms (kg), within 3 months prior to screening
• Have uncontrolled high blood pressure
• Have taken medications or alternative remedies to promote weight loss within 3 months prior to screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bimagrumab Dose 1 Reference Material	Bimagrumab	Participants will receive a single dose of bimagrumab subcutaneously (SC)
Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)	Bimagrumab	Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC
Bimagrumab Dose 1 Test Material + Tirzepatide (Coadministration)	Tirzepatide	Participants will receive a single dose of bimagrumab SC and a single dose of tirzepatide SC
Bimagrumab Dose 1 Test Material + Tirzepatide (Coformulation)	Bimagrumab + Tirzepatide Coformulation	Participants will receive a single dose of bimagrumab with tirzepatide SC
Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)	Bimagrumab	Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks
Bimagrumab Dose 2 Test Material + Tirzepatide (Coadministration)	Tirzepatide	Participants will receive bimagrumab SC and tirzepatide SC for 4 weeks
Bimagrumab Dose 2 Test Material + Tirzepatide (Coformulation)	Bimagrumab + Tirzepatide Coformulation	Participants will receive bimagrumab with tirzepatide SC for 4 weeks

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Bimagrumab Test Material	Predose through Week 13
PK: Cmax of Bimagrumab Reference Material	Predose through Week 13
PK: Cmax of Bimagrumab Coadministered with Tirzepatide	Predose through Week 13
PK: Cmax of Tirzepatide Coadministered with Bimagrumab	Predose through Week 16
PK: Cmax of Bimagrumab Coformulated with Tirzepatide	Predose through Week 16
PK: Cmax of Tirzepatide Coformulated with Bimagrumab	Predose through Week 16
PK: Area Under the Curve from Zero to Infinity AUC (AUC(0-∞)) of Bimagrumab Test Material	Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Reference Material	Predose through Week 13
PK: AUC(0-∞) of Bimagrumab Coadministered with Tirzepatide	Predose through Week 13
PK: AUC(0-∞) of Tirzepatide Coadministered with Bimagrumab	Predose through Week 16
PK: AUC(0-∞) of Bimagrumab Coformulated with Tirzepatide	Predose through Week 16
PK: AUC(0-∞) of Tirzepatide Coformulated with Bimagrumab	Predose through Week 16

Trial Locations

Locations (1)

Fortrea Clinical Research Unit; 🇺🇸 Dallas, Texas, United States